A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral ARN-75039 in Healthy Adu… (NCT05735249) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral ARN-75039 in Healthy Adult Subjects
United States94 participantsStarted 2023-01-23
Plain-language summary
ARN-75039 is proposed for the treatment of subjects with LASV infection, Lassa hemorrhagic fever, a potentially fatal human disease associated with Lassa viruses, with the most significant unmet medical need. ARN-75039-101 study was a randomized, double-blind, placebo-controlled study that assessed the safety, tolerability, and PK of escalating single and multiple doses of ARN 75039 when administered by the oral route in healthy adult subjects in six single ascending dose (SAD - Part 1) cohorts and five multiple ascending dose (MAD - Part 2) cohorts.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Is male or female, age 18 to 55 years, inclusive, at Screening.
✓. Body mass index (BMI) between 18.5 and 35 kg/m2, inclusive, at Screening.
✓. In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratory findings, and vital signs at Screening and Day -1 or 1.
✓. Hemoglobin, hematocrit, white blood cell count, absolute neutrophil count, and platelet count results within the laboratory reference range at Screening; subjects with Gilbert's disease with associated abnormalities of liver function tests are eligible for enrollment. Tests may be repeated at the discretion of the Investigator to confirm abnormalities.
✓. Estimated glomerular filtration rate (eGFR) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≥ 80 mL/min/1.73m2 at Screening
✓. Females of childbearing potential must practice effective contraception per national regulatory guidelines for clinical trials from Screening, throughout the study and for 28 days after the EOS visit.
✓. Females of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to dosing of study drug; for post-menopausal subjects, a blood sample will also be tested for follicle stimulating hormone (FSH) to confirm post-menopausal status (as verified by an FSH of ≥40). Surgically sterile females are eligible; however, proof via medical records will be required.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From first dose through the End-of-Study (EOS) visit: Part 1 (SAD), through Day 15/EOS; Food-effect cohort, through the second treatment period and Day 29/EOS; Part 2 (MAD), from Day 1 through Day 39/EOS.
2
Incidence of Treatment-Emergent Serious Adverse Events (TESAEs)
Timeframe: From first dose through the End-of-Study (EOS) visit: Part 1 (SAD), through Day 15/EOS; Food-effect cohort, through the second treatment period and Day 29/EOS; Part 2 (MAD), from Day 1 through Day 39/EOS.
✓. Males must agree to not donate sperm and/or to use condoms during sexual intercourse from the time of the first study drug administration and for 90 days following the last dose of study drug, and females must agree not to donate eggs from the time of the first study drug administration and for 60 days following the last dose of study drug.
Exclusion criteria
✕. Any clinically significant underlying illness in the opinion of the Investigator.
✕. Poor venous access.
✕. Inability to ingest all capsules of a multi-capsule dose within 5 minutes of ingestion of the first capsule.
✕. Prior exposure to ARN-75039.
✕. Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) at Screening; subjects with adequately treated HCV are eligible for enrollment.
✕. Positive test for SARS-CoV-2 infection on Day -1.
✕. Consumption of Seville oranges, grapefruit or grapefruit juice within 72 hours prior to Day 1 or during the study.
✕. History of drug or alcohol abuse within 1 year of Screening in the opinion of the investigator, or a positive test for drugs of abuse or alcohol at Screening or Day -1.